Understanding the Role of Quality by Design in Chromatographic Method Development

At the heart of QbD lies several principles, all leading toward the goal of building in quality from the earliest stages of drug development including knowledge retention, elimination of errors, and increased experimental scope. To be successful, QbD must be applied at every stage in the development and manufacturing process; however, one can consider processes within drug development on an individual basis to apply QbD principles.

One such process is the development of chromatographic methods for impurities and degradant studies. Ensuring both robustness and optimization from an efficiency standpoint is time-consuming and difficult. Generally, method development is carried out using a trial-and-error approach, and requires a large amount of manual data interpretation. However, QbD principles can be directly applied to this process resulting in better, more robust separations.